BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA MOZAIK 10CC STRIP

    MDR report key: 2810048 · Received October 24, 2012

    Report

    Report Number
    1121308-2012-00037
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    MQV
    PMA / PMN Number
    K063124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS SENT TO CDRH ON (B)(4) 2012 UNDER MFR REPORT NUMBER 2090010-2012-00011 USING THE INCORRECT FACILITY REG NUMBER (2090010). THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THE PATIENT HAD SURGERY WITH INTEGRA MOZAIK AT THE BEGINNING OF (B)(6). ON (B)(6) 2012, THE PATIENT PRESENTED TO THE SURGEON WITH A SEROMA. THE DOCTOR REOPENED THE SURGICAL WOUND; CULTURED AND CLEANED THE WOUND. THE PATIENT HAS NOT HAD FURTHER PROBLEMS. THE DOCTOR DIDN'T FEEL THERE WAS A PROBLEM WITH MOZAIK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA MOZAIK 10CC STRIP NA MQV INTEGRA LIFESCIENCES CORP. 105NB0244720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention